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Thrombotic Effects of Yellowstripe Scad

Primary Purpose

Thrombosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
YSS
Salmon
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thrombosis focused on measuring Thrombosis, Yellowstripe scad, Salmon, Healthy overweight subjects, Randomized crossover trial

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Malaysian
  • Overweight participants (BMI 23-27.4 kg/m2)

Exclusion Criteria:

  • Regular use of fish oil supplements during the last one month
  • Regular consumption of fish twice or more per week
  • Vegetarian who excluded all meat, fish, and poultry from their diet
  • Diagnosed with cardiovascular disease, haemostasis disorder, inflammatory disease, diabetes mellitus, hypertension, or other significant medical history that may prohibits the participation
  • Receiving warfarin or aspirin treatment, or medication to lower serum lipids, blood pressure, and inflammation
  • Women who are menopause, pregnant or lactating

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    YSS/salmon group

    Salmon/YSS group

    Arm Description

    YSS followed by salmon

    Salmon followed by YSS

    Outcomes

    Primary Outcome Measures

    Changes in hemostatic status assessed by immunoassay method
    Hemostatic markers including vWF-A2 and CD62b (p-selectin) in pg/mL are evaluated.

    Secondary Outcome Measures

    Changes in lipid and glucose profiles analysed by medical diagnostic laboratory
    Total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, and fasting blood glucose in mmol/L are evaluated.
    Changes in liver enzymes analysed by medical diagnostic laboratory
    Serum levels of alanine transaminase (ALT), aspartate transaminase (AST), alkaline Phosphatase (ALP) and gamma glutamyl transferase (GGT) in IU/L are determined.
    Changes in renal function analysed by medical diagnostic laboratory
    Serum levels of creatinine, urea, and electrolytes (sodium, potassium, and chloride) in mmol/L are determined.
    Changes in body mass index (BMI)
    Weight and height are combined to report BMI in kg/m^2
    Changes in blood pressure
    Seated systolic and diastolic blood pressures are taken in mmHg.

    Full Information

    First Posted
    May 30, 2017
    Last Updated
    August 14, 2017
    Sponsor
    Universiti Putra Malaysia
    Collaborators
    Ministry of Science, Technology and Innovation (MOSTI) Malaysia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03251014
    Brief Title
    Thrombotic Effects of Yellowstripe Scad
    Official Title
    The Thrombotic Effects of Yellowstripe Scad (YSS) Compared to Salmon Among Healthy Overweight Subjects: A Randomized Cross Over Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    May 9, 2017 (Actual)
    Study Completion Date
    May 9, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universiti Putra Malaysia
    Collaborators
    Ministry of Science, Technology and Innovation (MOSTI) Malaysia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aimed to determine the thrombotic effects of YSS compared with salmon among healthy overweight subjects. It hypothesized that YSS may result significant, favorable thrombotic effects and the effects may be similar with salmon.
    Detailed Description
    The project was a randomized, two-period, crossover trial with 8-week treatment periods and 8-week washout period. A total of 50 healthy overweight adults were recruited among staff and students in UPM. All the subjects were randomized into two groups. Each group was served with either cooked YSS (~265 g/ day) or salmon (~246 g/day) thrice per week. Blood and urine samples were collected for laboratory assessment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thrombosis
    Keywords
    Thrombosis, Yellowstripe scad, Salmon, Healthy overweight subjects, Randomized crossover trial

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    YSS/salmon group
    Arm Type
    Experimental
    Arm Description
    YSS followed by salmon
    Arm Title
    Salmon/YSS group
    Arm Type
    Experimental
    Arm Description
    Salmon followed by YSS
    Intervention Type
    Other
    Intervention Name(s)
    YSS
    Intervention Description
    Intervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks
    Intervention Type
    Other
    Intervention Name(s)
    Salmon
    Intervention Description
    Intervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks
    Primary Outcome Measure Information:
    Title
    Changes in hemostatic status assessed by immunoassay method
    Description
    Hemostatic markers including vWF-A2 and CD62b (p-selectin) in pg/mL are evaluated.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Changes in lipid and glucose profiles analysed by medical diagnostic laboratory
    Description
    Total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, VLDL-cholesterol, and fasting blood glucose in mmol/L are evaluated.
    Time Frame
    8 weeks
    Title
    Changes in liver enzymes analysed by medical diagnostic laboratory
    Description
    Serum levels of alanine transaminase (ALT), aspartate transaminase (AST), alkaline Phosphatase (ALP) and gamma glutamyl transferase (GGT) in IU/L are determined.
    Time Frame
    8 weeks
    Title
    Changes in renal function analysed by medical diagnostic laboratory
    Description
    Serum levels of creatinine, urea, and electrolytes (sodium, potassium, and chloride) in mmol/L are determined.
    Time Frame
    8 weeks
    Title
    Changes in body mass index (BMI)
    Description
    Weight and height are combined to report BMI in kg/m^2
    Time Frame
    8 weeks
    Title
    Changes in blood pressure
    Description
    Seated systolic and diastolic blood pressures are taken in mmHg.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Malaysian Overweight participants (BMI 23-27.4 kg/m2) Exclusion Criteria: Regular use of fish oil supplements during the last one month Regular consumption of fish twice or more per week Vegetarian who excluded all meat, fish, and poultry from their diet Diagnosed with cardiovascular disease, haemostasis disorder, inflammatory disease, diabetes mellitus, hypertension, or other significant medical history that may prohibits the participation Receiving warfarin or aspirin treatment, or medication to lower serum lipids, blood pressure, and inflammation Women who are menopause, pregnant or lactating
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Su Peng Loh, PhD
    Organizational Affiliation
    Universiti Putra Malaysia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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